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Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC


Phase 2
N/A
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

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Trial Information

Phase II Trial of a 96-Hour Continuous Infusion of Paclitaxel Followed by Cisplatin for Patients With Stage III/IV and Relapsed NSCLC


This is a Phase II study of paclitaxel (Taxol R) administered as a 96-hour (4 day)
continuous infusion followed by a bolus of cisplatin for previously untreated patients with
stage III/IV or relapsed non-small cell lung cancer (NSCLC). The goal of this phase II
study is to determine the response rate of this infusional paclitaxel and bolus cisplatin
regimen in patients with advanced NSCLC. In addition, the plasma levels of paclitaxel will
be measured, and the in vitro paclitaxel chemosensitivity of the tumor cells from as many
patients as possible will be determined. This will allow further study of the relationship
between in vitro drug sensitivity, achievable plasma concentrations of paclitaxel, and
patients' response to therapy.

Inclusion Criteria


DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer, including: Squamous cell carcinoma,
Adenocarcinoma, Large cell carcinoma, Mixed histologies in the absence of a predominant
small cell component.

Eligible Stages Include:

Stage IV, Stage IIIA/B ineligible for resection or radiotherapy, Postsurgical recurrence
that is histologically or cytologically proven.

CNS Metastases Allowed Provided:

Radiotherapy completed prior to entry.

No requirement for concurrent steroids.

No carcinomatous meningitis.

No epidural metastases.

Measurable disease not required.

PRIOR/CONCURRENT THERAPY:

Biologic Therapy: Not specified.

Chemotherapy: No prior chemotherapy for lung cancer.

Endocrine Therapy: Not specified.

Radiotherapy: No prior chest irradiation for lung cancer.

Surgery: Prior surgery allowed.

PATIENT CHARACTERISTICS:

Age: 18 and over.

Performance Status: ECOG 0-2.

Hematopoietic:

Absolute granulocyte count greater than 2,000.

Platelet count greater than 100,000.

Hepatic: Bilirubin no greater than 1.5 mg/dL.

Renal: Creatinine no greater than 1.5 mg/dL.

Cardiovascular:

No CHF unless fully compensated.

No second- or third-degree heart block.

No uncontrolled, symptomatic atrial dysrhythmia except sinus bradycardia.

No sustained ventricular tachycardia.

No MI within 3 months.

OTHER:

No uncontrolled infection unless due to an obstructed bronchus.

No major psychiatric problems requiring hospitalization.

No psychotropic medications such as phenothiazines.

No contraindication to transfusion, if required.

No second malignancy within 5 years except: Nonmelanomatous skin cancer.

In situ cervical cancer.

No pregnant or nursing women.

Effective contraception required of fertile patients.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

950198

NCT ID:

NCT00001450

Start Date:

September 1995

Completion Date:

June 2000

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Chemotherapy
  • In Vitro Testing
  • Infusional
  • Lung Neoplasm
  • Pharmacokinetics
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892